1. FIELD

  • Cosmetic products
  • Food supplements (nutraceuticals)
  • Chemistry (dangerous substances/preparations, biocides, …)

2. SERVICES

  • Research work: scientific, bibliographical and regulatory studies (EU, USA, Canada, other countries…)
  • Regulatory compliance:

    Cosmetic Products:
    European Union (Directive 76/768/EEC compliance):
    - Notifications to the Competent Authorities
    - Declarations to Poison Centres
    - Set up of the Product Information Package ("Dossier")
    - Safety assessment of finished products based on the toxicological profile of the ingredients. Toxicological testing performed in collaboration with BIO-HC laboratories (Bordeaux, France)
    - Claim substantiation of finished products
    - Quality Control : physicochemical and microbiological analyses COLIPA & ISO standards)
    USA:
    - Voluntary Cosmetic Registration Programme (VCRP)
    - Product Information Package (PIP): labelling and packaging review
    - OTC (Over The Counter) products: registration with the FDA in close collaboration with American regulatory affairs consulting firms

Dietary/Food Supplements (Nutraceuticals):
European Union (Directive 2002/46/EC compliance):
- Comprehensive registration package
USA & Canada (21CFR and Health/Santé Canada compliance):
- Comprehensive registration package

Chemical Industry:
European Union:
Dangerous Substances & Preparations
- Compliance with Directives 92/32/EEC & 1999/45/EC: classification and labelling
- MSDS authoring according to Directive 2001/58/EC. Use of the "Lisam Systems" software
- REACH and GHS readiness
Biocides
- Full compliance with Directive 98/8/EC
USA
- Classification and labelling of dangerous chemicals and MSDS authoring according to 29CFR 1910.1200 (OSHA/ANSI) et GHS formats

  • Training & consulting in international norms (cGMP, Colipa, ISO, ANSI, …):
    - Organisation of seminars
    - Quality audits GMP cosmétiques :
    ISO/DIS 22716.